Comparing Misoprostol and Oxytocin in UnijectTM for Postpartum Hemorrhage (PPH) Prevention in Mali

This study has been withdrawn prior to enrollment.
Sponsor:
Collaborators:
The Aga Khan Foundation
Guttmacher Institute
Information provided by (Responsible Party):
Gynuity Health Projects
ClinicalTrials.gov Identifier:
NCT01487278
First received: December 5, 2011
Last updated: January 8, 2014
Last verified: January 2014
  Purpose

This is a large, community-based, cluster-randomized trial to compare routine prophylactic use of 600 mcg oral misoprostol and 10 IU oxytocin delivered by UnijectTM intramuscularly during the third stage of labor.


Condition Intervention
Postpartum Hemorrhage
Drug: misprostol
Device: UnijectTM

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Preventing Postpartum Hemorrhage: Examining Two Strategies for PPH Prevention in Communities: Misoprostol and Oxytocin in UnijectTM in Mali

Resource links provided by NLM:


Further study details as provided by Gynuity Health Projects:

Primary Outcome Measures:
  • Mean change in hemoglobin [ Time Frame: during 3rd trimester and 1-3 days postpartum ] [ Designated as safety issue: No ]
    To establish the comparable effectiveness of two technologies, individual pre- and post-delivery Hb measures will be taken to calculate change in Hb. This will be done using a Hemocue Hemoglobin machine + cuvette (HemoCue, Angelholm, Sweden). The Hemocue is a simple means of collecting Hb measures at the community-level where traditional laboratory techniques are not feasible.


Secondary Outcome Measures:
  • occurrence and management of side effects [ Time Frame: 1 hour postpartum ] [ Designated as safety issue: Yes ]
    nausea, vomiting, diarrhea, shivering, fever

  • correct timing of drug administration [ Time Frame: collected immediately following birth, verified 1-3 days postpartum ] [ Designated as safety issue: Yes ]
    administration of the drug after the birth of the baby and verifying no twin, before the expulsion of the placenta

  • change in hemoglobin ≥ 2 g/dL [ Time Frame: during third trimester and 1-3 days postpartum ] [ Designated as safety issue: No ]
  • additional interventions [ Time Frame: during birth and 1-3 days postpartum ] [ Designated as safety issue: No ]
    use of additional uterotonics, manual removal of placental fragments, etc

  • referrals [ Time Frame: 1-3 days postpartum ] [ Designated as safety issue: No ]
    referral requested, transfers carried out, reasons for incomplete referrals/transfers

  • acceptability [ Time Frame: 1-3 days postpartum ] [ Designated as safety issue: No ]
    acceptability according to woman of study medication, care received, side effects experienced


Enrollment: 0
Arms Assigned Interventions
Experimental: Misoprostol
600 mcg oral misoprostol administered during the third stage of labor
Drug: misprostol
600 mcg misoprostol oral
Other Name: Cytotec
Experimental: UnijectTM
10 IU oxytocin delivered IM with UnijectTM during he third stage of labor
Device: UnijectTM
10 IU oxytocin delivered intramuscularly with UnijectTM

Detailed Description:

This study will assess the programmatic implications (including feasibility, acceptability, costs, risks and benefits) at the community level of the introduction of misoprostol and/or oxytocin in UnijectTM for the prevention of PPH and will help to identify the appropriate niche for both drugs.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • women delivering at home with a trained study provider who are able to provide informed consent

Exclusion Criteria:

  • women with known contraindications to prostaglandins
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01487278

Locations
Mali
Villages in Mopti
Mopti, Mali
Sponsors and Collaborators
Gynuity Health Projects
The Aga Khan Foundation
Guttmacher Institute
Investigators
Principal Investigator: Ayisha R Diop, MPH Gynuity Health Projects
Principal Investigator: Laura J Frye, MPH Gynuity Health Projects
Principal Investigator: Yacouba Kone, M.D The Aga Khan Foundation
  More Information

Additional Information:
No publications provided

Responsible Party: Gynuity Health Projects
ClinicalTrials.gov Identifier: NCT01487278     History of Changes
Other Study ID Numbers: 2.4.8
Study First Received: December 5, 2011
Last Updated: January 8, 2014
Health Authority: Mali: Ministry of Health

Keywords provided by Gynuity Health Projects:
postpartum hemorrhage
prevention
misoprostol
Uniject
oxytocin

Additional relevant MeSH terms:
Hemorrhage
Postpartum Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage
Oxytocin
Misoprostol
Oxytocics
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Anti-Ulcer Agents
Gastrointestinal Agents
Abortifacient Agents, Nonsteroidal
Abortifacient Agents

ClinicalTrials.gov processed this record on July 20, 2014